Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 2:33 PM
Study NCT ID:
NCT00924794
Status:
TERMINATED
Last Update Posted:
2015-04-20
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'whyStopped': 'This complex study included a pilot and a main part. As the results of the pilot study were satisfying and conclusive, the main study was not performed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.', 'timeFrame': 'At the end of the study.'}, {'measure': 'HPV-types as single group considered as persistent infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.', 'timeFrame': 'At the end of the study.'}], 'secondaryOutcomes': [{'measure': 'HPV-types as individual types or as different groups considered as new infections in recurrent conizations presenting high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.', 'timeFrame': 'At the end of the study.'}, {'measure': 'HPV-types as individual types or as different groups considered as persistent infections in recurrent conizations presenting high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.', 'timeFrame': 'At the end of the study.'}]}, 'conditionsModule': {'conditions': ['Infections, Papillomavirus']}, 'referencesModule': {'references': [{'pmid': '24631451', 'type': 'DERIVED', 'citation': 'Vintermyr OK, Iversen O, Thoresen S, Quint W, Molijn A, de Souza S, Rosillon D, Holl K. Recurrent high-grade cervical lesion after primary conization is associated with persistent human papillomavirus infection in Norway. Gynecol Oncol. 2014 May;133(2):159-66. doi: 10.1016/j.ygyno.2014.03.004. Epub 2014 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a register-based, epidemiological study of HPV type distribution in women aged 18 years and above with recurrent conization following a primary conization for high grade lesions/ microinvasive carcinomas. This study will involve data collection from different databases in the Cancer Registry of Norway.', 'detailedDescription': 'This protocol posting has been updated following Protocol Amendment 1 (02 April 2010). The sections impacted are: enrolment, outcome measures and eligibility criteria.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 18 years and above registered in the Cancer Registry of Norway.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must meet the following criteria at study entry:\n\n* Women aged 18 years and above at the time of the collection of the primary cone specimen;\n* Who have undergone for the first time a conization due to high grade lesions or microinvasive cervical carcinomas, histologically diagnosed in 2003, with possible extension backwards in time;\n* Availability of recurrent cone specimen with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer;\n* Availability in designated local laboratories of the primary and recurrent cone specimens;\n* The cone specimen was adequately preserved;\n* Written informed consent obtained from the subject. If the subject is deceased, the cone and biopsy specimens will be used according to prior approval from the Ethics Committee.\n\nExclusion Criteria:\n\nNone.'}, 'identificationModule': {'nctId': 'NCT00924794', 'briefTitle': 'Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Retrospective Epidemiological Study of Natural History of HPV Infections in Women Aged 18 Years and Above With Recurrent Conization Following a Primary Conization for High Grade Lesions/ Microinvasive Cervical Carcinomas, in Norway', 'orgStudyIdInfo': {'id': '112674'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Women aged 18 years and above, diagnosed with high grade lesions or microinvasive cervical carcinomas in primary conization performed and registered in the Cancer Registry of Norway, and presenting with recurrent conization with high grade lesions or microinvasive cervical carcinoma or invasive cervical carcinoma.', 'interventionNames': ['Procedure: Cancer Registry of Norway (database)']}], 'interventions': [{'name': 'Cancer Registry of Norway (database)', 'type': 'PROCEDURE', 'description': 'Review of database to identify women with primary conization presenting with high grade lesions/ microinvasive cervical carcinomas. Recurrent cones with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer will be identified for all women with primary cones.', 'armGroupLabels': ['Cohort A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5053', 'city': 'Bergen', 'country': 'Norway', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}